A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury
Completed · Not applicable
Conditions studied: Moral Injury
In brief
The objective of this project is to test the efficacy of an individual treatment for post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured by a six-month follow-up assessment. Veterans who kill in war are at increased risk for functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be provided following existing PTSD treatments, filling a critical gap for Veterans with moral injury who continue to suffer from mental health symptoms and functional difficulties.
Key facts
- Study ID
- NCT03764033
- Run by
- VA Office of Research and Development
- People needed
- 100
- Starts
- 2019-08-12
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2025-11-20
Who can join
Age: 18 and older, up to 82. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veterans 18-82 years of age
- Veterans who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Post-traumatic Stress Disorder (PTSD) or score 23 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) screening interview.
- Veterans who endorsed killing or being responsible for the death of another in a war zone and report continued distress regarding these events
- Distress will be operationalized by a positive response to one or more of the nine self-directed moral injury items on the Expressions of Moral Injury Scale-Military Version (EMIS-M) or item #4 on the Moral Injury Events Scale (MIES)
- Veterans who have initiated or completed an evidence-based treatment for PTSD, such as Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE)
- If receiving CPT or PE, Veterans must complete treatment and wait two weeks prior to screening
- If receiving prescription medication for PTSD, Veterans must be one month stable on medication and not make any changes to medication during the course of the active treatment phase of the study
You may not qualify if…
- Veterans with current or lifetime diagnosis of a psychotic disorder or current untreated/unmanaged mania.
- Veterans with recent suicidal or homicidal behaviors (chronic suicidal ideation is not exclusionary)
- Veterans with recent psychiatric hospitalizations
- Veterans with moderate or severe alcohol or drug dependence within the past three months
- Veterans receiving individual therapy for PTSD or those planning to start skills-based or trauma-focused group psychotherapy will be excluded
- However, these Veterans will be offered the opportunity to be screened again after completion of individual PTSD therapy or once they are three months stable in group treatment, with no plans to discontinue this treatment
Where it is running
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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